CClinicalTrials.gg
RecruitingNCT05416489VIDLARTRAQUpdated Sep 15, 2025

C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy

An interventional study of C-MAC videolayngoscopy technique and Laryngoscopy technique in Intubated Patients and Percutaneous Tracheostomy, sponsored by Hospital Clinico Universitario de Santiago. Recruiting at 2 sites in Spain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Hospital Clinico Universitario de Santiago · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

When preparing an ICU patient for percutaneous dilational tracheostomy, correct positioning of the endotracheal tube is important. During the procedure, it is possible to puncture the cuff. Tracheal tube cuff puncture can lead to failure of ventilation, loss of positive end-expiratory pressure, and possible aspiration of gastric contents blood or secretions. To minimize the risk, in our ICU, we withdraw the endotracheal tube under direct laryngoscopic vision until the cuff is visible at the vocal cords. This maneuver would also facilitate insertion of the Seldinger needle and insertion of the tracheostomy tube below the endotracheal tube. However, this maneuver to remove the endotracheal tube under direct laryngoscopy can sometimes be difficult. ICU patients present frecuently difficult laryngoscopic vision due to airway edema or secretions. In ICU, the videolaryngopy has been shown to be superior to direct laryngoscopy in visualization the upper airway, allowing better laryngoscopic vision.

Read the detailed description

The investigators aim to compare C-MAC videolaryngoscopy versus conventional direct laryngoscopy for positioning the tracheal tube to facilitate insertion of the Seldinger needle and the tracheostomy tube below the endotracheal tube during percutaneous tracheostomy.

02

Conditions studied

  • Intubated Patients
  • Percutaneous Tracheostomy

Keywords

  • Tracheostomy
  • Critical care
  • Videolaryngoscopy
  • Direct laryngoscopy
  • Airway management
03

In context

Lead sponsor

Hospital Clinico Universitario de Santiago is the lead sponsor of 33 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ICU intubated patients that require a percutaneous dilational tracheostomy for clinical reasons (prolonged mechanical ventilation, airway protection or weaning failure).

Exclusion criteria

Exclusion Criteria:

  • Patients younger than 18 years and older than 85 years
  • Trachea and neck abnormalities.
  • Soft tissue infection in the neck.
  • History of neck surgery.
  • Coagulation disorders or changes in coagulation parameters (platelet count \< 50.000 mm3, an activated partial thromboplastin time 1.5-fold longer than the control value, and international normalized ratio > 1.5).
  • Consent refusal for participating in the trial.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Traditional direct laryngoscopy technique

    Endotracheal tube will be removed before percutaneous tracheostomy using a traditional direct laryngoscopy technique.

    Device: Laryngoscopy technique

  • Active comparator
    C-MAC videolaryngoscope technique

    Endotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscope technique.

    Device: C-MAC videolayngoscopy technique

Interventions

  • DeviceC-MAC videolayngoscopy technique

    Endotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscopy.

  • DeviceLaryngoscopy technique

    Endotracheal tube will be removed before percutaneous tracheostomy using a laryngoscopy

06

What researchers measure

Primary outcomes

  1. Introduction of the Seldinger needle below the endotracheal tube

    Percentage of patients in whom the introduction of the Seldinger needle is below the tip of the endotracheal tube

    Time frame: during the procedure

Secondary outcomes

  1. Puncture of the cuff of the endotracheal tube with the Seldinger needle

    Percentage of patients suffering puncture the cuff of the endotracheal tube with the Seldinger needle

    Time frame: during the procedure

  2. patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannula

    Percentage of patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannula

    Time frame: during the procedure

  3. Laryngoscopy vision using de Modified Cormack-Lehane grade of glottic view

    Differences in laryngoscopy vision using de modified Cormack-Lehane grade of glottic view Modified Cormack-Lehane grade of glottic view: I: full view of the glottis (better outcome) IIa: partial view of the glottis IIb: arytenoid or posterior part of the vocal cords just visible III: only epiglottis visible IV: neither glottis nor epiglottis visible (worse outcome)

    Time frame: during the procedure

  4. Difficulty of removing the endotracheal tube

    Differences in the difficulty of removing the endotracheal tube due to poor visualization, secretions.... Operator-assessed subjective difficulty of removing the endotracheal tube: No difficulty, mild difficulty, moderate difficulty, severe difficulty.

    Time frame: during the procedure

  5. Difficulty of performing percutaneous tracheotomy

    Differences in the difficulty of performing percutaneous tracheotomy Operator-assessed subjective difficulty of performing percutaneous tracheotomy: No difficulty, mild difficulty, moderate difficulty, severe difficulty.

    Time frame: during the procedure

  6. Complications

    Percentage of complications

    Time frame: during the ICU stay

07

Study locations

2 of 2 sites recruiting
  • University Clinical Hospital of Santiago de Compostela
    Santiago de Compostela, A Coruña 15866, Spain
    • Manuel Taboada Muñiz, Ph.D. · Contact · manutabo@yahoo.es · +34678195618
    • María Teresa Cabaleiro Ocampo · Contact · +34 981 951 628
    Recruiting
  • University Clinical Hospital of Santiago de Compostela
    Santiago de Compostela, A Coruña 15866, Spain
    Recruiting
08

References and documents

Publications

  • Johnson-Obaseki S, Veljkovic A, Javidnia H. Complication rates of open surgical versus percutaneous tracheostomy in critically ill patients. Laryngoscope. 2016 Nov;126(11):2459-2467. doi: 10.1002/lary.26019. Epub 2016 Apr 14. PubMed 27075530 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05416489
Lead sponsor
Hospital Clinico Universitario de Santiago
Responsible party
Manuel Taboada Muñiz (Clinical Professor, Hospital Clinico Universitario de Santiago) — Principal investigator
First posted
Jun 13, 2022
Start date
Jan 1, 2022
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Sep 15, 2025

Study contacts

Manuel Taboada, Ph.D.
Contact
manutabo@yahoo.es
0034981950674

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion